On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection.
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Molina Jean-Michel, Capitant Catherine, Spire Bruno, Pialoux Gilles, Cotte Laurent, Charreau Isabelle, Tremblay Cecile, Le Gall Jean-Marie, Cua Eric, Pasquet Armelle, Raffi François, Pintado Claire, Chidiac Christian, Chas Julie, Charbonneau Pierre, Delaugerre Constance, Suzan-Monti Marie, Loze Benedicte, Fonsart Julien, Peytavin Gilles, Cheret Antoine, Timsit Julie, Girard Gabriel, Lorente Nicolas, Préau Marie, Rooney James F, Wainberg Mark A, Thompson David, Rozenbaum Willy, Doré Veronique, Marchand Lucie, Simon Marie-Christine, Etien Nicolas, Aboulker Jean-Pierre, Meyer Laurence, Delfraissy Jean-François, ANRS IPERGAY Study Group
Аннотация
METHODS: We conducted a double-blind, randomized trial of antiretroviral therapy for preexposure HIV-1 prophylaxis among men who have unprotected anal sex with men. Participants were randomly assigned to take a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or placebo before and after sexual activity. All participants received risk-reduction counseling and condoms and were regularly tested for HIV-1 and HIV-2 and other sexually transmitted infections.
RESULTS: Of the 414 participants who underwent randomization, 400 who did not have HIV infection were enrolled (199 in the TDF-FTC group and 201 in the placebo group). All participants were followed for a median of 9.3 months (interquartile range, 4.9 to 20.6). A total of 16 HIV-1 infections occurred during follow-up, 2 in the TDF-FTC group (incidence, 0.91 per 100 person-years) and 14 in the placebo group (incidence, 6.60 per 100 person-years), a relative reduction in the TDF-FTC group of 86% (95% confidence interval, 40 to 98; P=0.002). Participants took a median of 15 pills of TDF-FTC or placebo per month (P=0.57). The rates of serious adverse events were similar in the two study groups. In the TDF-FTC group, as compared with the placebo group, there were higher rates of gastrointestinal adverse events (14% vs. 5%, P=0.002) and renal adverse events (18% vs. 10%, P=0.03).
CONCLUSIONS: The use of TDF-FTC before and after sexual activity provided protection against HIV-1 infection in men who have sex with men. The treatment was associated with increased rates of gastrointestinal and renal adverse events. (Funded by the National Agency of Research on AIDS and Viral Hepatitis [ANRS] and others; ClinicalTrials.gov number, NCT01473472.).